BREO ELLIPTA Drug Patent Profile

When do Breo Ellipta patents expire, and when can generic versions of Breo Ellipta launch?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-eight patent family members in thirty-three countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Breo Ellipta

Breo Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $2.0bn, indicating a strong incentive for generic entry (peak sales were $2.8bn in 2021).

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BREO ELLIPTA

International Patents:	188
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	49
Patent Applications:	102
Drug Prices:	Drug price information for BREO ELLIPTA
Drug Sales Revenues:	Drug sales revenues for BREO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREO ELLIPTA
What excipients (inactive ingredients) are in BREO ELLIPTA?	BREO ELLIPTA excipients list
DailyMed Link:	BREO ELLIPTA at DailyMed

See drug prices for BREO ELLIPTA

See drug sales revenues for BREO ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BREO ELLIPTA

Constraining patent/regulatory exclusivity:

11,116,721*PED

NDA:

204275

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BREO ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline	PHASE4
Theravance Biopharma	PHASE4
University of Tennessee Graduate School of Medicine	PHASE4

See all BREO ELLIPTA clinical trials

Pharmacology for BREO ELLIPTA

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for BREO ELLIPTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREO ELLIPTA	Powder for Inhalation	fluticasone furoate; vilanterol trifenatate	100 mcg/25 mcg	204275	1	2025-06-16

US Patents and Regulatory Information for BREO ELLIPTA

BREO ELLIPTA is protected by five US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,116,721.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	7,439,393*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	8,511,304*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	8,534,281*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	11,116,721*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	7,439,393*PED				Y

Expired US Patents for BREO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	7,629,335
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	7,101,866
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	5,873,360
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	7,629,335
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	6,759,398
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	7,776,895

International Patents for BREO ELLIPTA

When does loss-of-exclusivity occur for BREO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	207531
Brazil	PI0514346	acionador de folha para uso de um dispensador de medicamento, e, dispensador de medicamento
Norway	20041041
Canada	2555347	COMPTEUR A UTILISER AVEC UN DISTRIBUTEUR DE MEDICAMENT (COUNTER FOR USE WITH A MEDICAMENT DISPENSER)
South Africa	200300932	6.Alpha., 9.Alpha.-difluoro-17.Alpha.-'(2-furanylcaboxyl)oxy!-11.Beta.-hydroxy-16.Alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothioic acid s-fluoromethyl ester as an anti-inflamatory agent.
Australia	2003207016	PHARMACEUTICAL FORMULATION FOR ADMINISTRATION BY INHALATION COMPRISING AN ANDROSTANE DERIVATIVE AND A BETA-2-ADRENORECEPTOR FOR THE TREATMENT OF INFLAMMATORY AND ALLERGIC CONDITIONS

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	C01305329/01	Switzerland		PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
1425001	2014/024	Ireland		PRODUCT NAME: VILANTEROL OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001	132014902250414	Italy		PRODUCT NAME: VILANTEROLO O UN SUO SALE O SOLVATO(RELVAR ELLIPTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/886/001-006, 20131113
1305329	CA 2008 00022	Denmark
1425001	122014000051	Germany		PRODUCT NAME: VILANTEROL ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Market Dynamics and Financial Trajectory of BREO ELLIPTA

Last updated: October 6, 2025

Introduction

BREO ELLIPTA (vilanterol/trifenatate inhalation powder) is a once-daily, fixed-dose combination medication approved for the management of asthma and chronic obstructive pulmonary disease (COPD). Commercialized by GlaxoSmithKline (GSK), BREO ELLIPTA has become a significant player in respiratory therapeutics, driven by increasing global prevalence of respiratory conditions and evolving treatment paradigms. This analysis explores the market dynamics influencing BREO ELLIPTA's trajectory and provides an in-depth forecast of its financial outlook within the competitive respiratory drug landscape.

Market Overview and Growth Drivers

The global respiratory drug market is experiencing robust growth, projected to reach approximately USD 56 billion by 2027, driven by rising disease prevalence, aging populations, and advancements in inhalation therapies [1]. COPD remains the primary indication for BREO ELLIPTA, with over 200 million cases worldwide, and asthma affecting an estimated 262 million people globally [2]. The increasing adoption of long-acting bronchodilators and inhaled corticosteroids has expanded the market for combination inhalers such as BREO ELLIPTA.

Key drivers inkluder**:

• Rising Prevalence of COPD and Asthma: As populations age, the incidence of COPD and asthma surges, especially in low- and middle-income countries. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) reports undiagnosed cases often across demographics, creating unmet medical needs [3].

• Shift Towards Fixed-Dose Combinations: Increasing preference for once-daily inhalers improves patient adherence, enlarging market acceptance for products like BREO ELLIPTA.

• Regulatory Approvals and Label Expansion: GSK has expanded BREO ELLIPTA’s indications, including use in adolescent asthma, broadening its potential patient base.

• Innovative Delivery Technologies: The strength of GSK’s Ellipta device lies in ease of use and consistent drug delivery, potentiating market penetration.

Market Challenges

Despite strong growth signals, BREO ELLIPTA faces competitive and regulatory hurdles:

• Competitive Landscape: The inhalation market is crowded, with direct competitors such as Advair (fluticasone/salmeterol), Symbicort (budesonide/formoterol), and Breztri Aerosphere (budesonide/glycopyrrolate/formoterol). These products are well-established, and market share shifts can be swift based on pricing, clinical efficacy, and formulary access.

• Generic and Biosimilar Threats: Although inhalers face challenges from generics due to device-specific patents, patent cliffs for some competitors threaten market dynamics in the coming years.

• Regulatory Environment: Evolving standards regarding inhaler device design, labeling, and drug subsidies can impact market execution.

Financial Trajectory and Revenue Outlook

Past Performance:

GSK reported that BREO ELLIPTA generated approximately USD 2.5 billion globally in 2022, representing a significant portion of the company's respiratory franchise, with steady growth over previous years [4].

Forecasted Trends:

• Growth in Emerging Markets: Expanding healthcare infrastructure and increasing disease awareness position emerging markets as key growth areas, with estimates suggesting these regions could account for 40% of BREO ELLIPTA’s sales by 2030.

• Clinical Trials and Label Expansion: Ongoing trials for pediatric asthma, COPD maintenance, and potential triple therapy options could lead to label extensions, boosting sales.

• Pricing and Reimbursement Dynamics: Pricing strategies and insurance coverage in mature markets like the U.S. and EU will influence revenue growth and profit margins.

Projected Revenue Trajectory:

Industry analysts project a compounded annual growth rate (CAGR) of approximately 6-8% for BREO ELLIPTA over the next five years, driven by expanding indications, geographic reach, and clinical differentiation. Revenues are forecasted to top USD 4 billion globally by 2028, with the highest gains anticipated from Asia-Pacific and Latin America.

Impact of Patent Protections and Lifecycle Management

Patent protections for BREO ELLIPTA are set to expire gradually from 2026 onward. GSK has invested in lifecycle management strategies, including formulation tweaks and device enhancements, to sustain market share. Additionally, GSK’s focus on digital health integration and remote monitoring could enhance treatment adherence, further stabilizing revenues.

Competitive Positioning and Market Share

BREO ELLIPTA maintains a strong market position due to its patient-friendly dosing, innovative device technology, and broad label. However, intense competition from Advair and Symbicort, combined with evolving formularies favoring cost-effective generics, could compress margins. Strategically, GSK's focus on pipeline expansion and therapeutic differentiation remains crucial to maintaining a dominant position.

Regulatory and Pricing Environment Impact

Regulatory bodies, including the FDA and EMA, continue to scrutinize inhalation devices for safety and efficacy. GSK's proactive engagement with regulatory agencies has expedited approvals for new formulations and indications. Pricing pressure, especially in healthcare systems with stringent cost controls, necessitates operational agility. Value-based reimbursement models emphasizing outcomes may influence revenue models favoring innovative therapies.

Conclusion

BREO ELLIPTA's market dynamics hinge on epidemiological trends, competitive developments, regulatory landscape, and therapeutic innovations. The drug's financial trajectory appears favorable given current growth trends, with substantial upside potential from geographic expansion, indication broadening, and device enhancements. However, competitive pressures and patent expirations pose medium-term risks requiring strategic mitigation.

Key Takeaways

• Robust Market Growth: The global respiratory therapeutic market underpins BREO ELLIPTA’s strong revenue prospects, projected to reach USD 4 billion by 2028.

• Strategic Differentiation: GSK’s emphasis on device technology and label expansion sustains competitive advantage amid a crowded market.

• Emerging Markets: Future revenue growth will be increasingly driven by penetration into high-growth regions such as Asia-Pacific and Latin America.

• Lifecycle Management: Patent expirations approaching from 2026 necessitate innovation and strategic pipeline investments to sustain market share.

• Pricing and Reimbursement: Evolving health policies will influence profitability, emphasizing the importance of value-driven market positioning.

FAQs

1. What are the primary factors influencing BREO ELLIPTA's international market expansion?
Market expansion is driven by rising respiratory disease prevalence in emerging economies, healthcare infrastructure development, regulatory approvals, and localized pricing strategies.

2. How do BREO ELLIPTA's clinical advantages compare to its competitors?
Its once-daily dosing, user-friendly Ellipta device, and expanded indications provide convenience, adherence, and therapeutic flexibility, positioning it favorably compared to some competitors with multiple daily dosing regimens.

3. What risks could impact BREO ELLIPTA’s future sales?
Patent expirations, intense competition, potential regulatory hurdles, and pricing pressures pose significant risks that could impact revenues unless mitigated by innovation and strategic diversification.

4. How does BREO ELLIPTA fit within GSK’s overall respiratory portfolio?
BREO ELLIPTA remains a cornerstone product, complementing GSK’s broader inhalation offerings and pipeline, with ongoing efforts to expand its therapeutic and geographic footprint.

5. What role will digital health innovations play in BREO ELLIPTA’s future market performance?
Digital health tools, such as remote inhaler monitoring and adherence apps, are poised to enhance treatment adherence, improve outcomes, and support personalized medicine, thereby bolstering BREO ELLIPTA’s market position.

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References:

[1] Market Research Future, "Respiratory Device Market Analysis," 2022.
[2] Global Initiative for Asthma, "Global Strategy for Asthma Management and Prevention," 2022.
[3] GOLD Reports, "Global Strategy for COPD Management," 2022.
[4] GSK Annual Report, 2022.